DevSecOps for Medical Devices: Ship Fast. Prove it Easily.

The “good enough for SaaS” approach won’t work for the FDA. Here’s how Helm transforms security into submission‑ready evidence.

TL;DR

• Medical device DevSecOps lives under a dual mandate: deliver quickly while documenting everything defensibly.
• Standard SCA/SAST tools can find issues, but they fall short. They don’t explain risk in the context of your device or generate FDA‑ready evidence.
• Helm bridges engineering and regulatory affairs/ quality assurance (RA/QA): It merges multiple SBOMs, prioritizes vulnerabilities by device impact, captures justifications, and exports evidence packs you need for  eSTAR or audits.
• Rollout in 30 days: connect CI/CD → triage with policy → standardize evidence → scale across your entire product portfolio.

One workflow, two stakeholders. Engineers keep velocity; RA/QA gets proof.

Why DevSecOps in MedTech “hits different”

Shipping secure code is a basic requirement everywhere. In regulated healthcare, however, you also need a traceable story for every decision that impacts patient safety:

• Why a vulnerability wasn’t patched
• How it is mitigated
• Where it exists in the product lineage (CVE → component → device version)
• Who reviewed and approved the decision, and when

That’s the critical difference between “secure enough to ship” and defensible enough to submit.

The SBOM Reality (and why SCA isn’t enough)

Modern medical devices have complex stacks: real‑time OSs, third‑party libraries, optional attachments, and field‑configurable variants. One device often means multiple SBOMs - and thousands of CVEs.

SCA tools are great at finding vulnerabilities, but they can’t answer questions that regulators and customers will ask:  

• Is this issue exploitable in your device?
• If not patched, what’s the rationale?
• Which compensating controls have you put in place to reduce risk?
• Show the version‑to‑version change history and approvals.

Bottom line: You don’t need more alerts - you need evidence.

Shift‑Left, Submit Right: The Helm Workflow

Helm connects your engineering reality to regulatory expectations in one flow.

1) Plug into CI/CD 

• Auto‑ingest SBOMs at build
• Gate releases on policy (exploitability, severity, component age)
• Flag risky diffs before they hit main

2) Triage What Matters

• AI explanations tuned to your device
• Prioritize exploitability + impact, not just CVSS
• Fast suppress/accept with required rationale

3) Capture the Evidence 

• Standardized justification templates (“why we didn’t patch”)
• Compensating controls (e.g., process isolation, ACLs) auto‑attached
• Reviewer sign‑off + timestamps + linked artifacts

4) Maintain Traceability

• Link CVE → component → device version across variants
• Keep diffs and approvals by release
• Reuse justifications across similar builds

5) Export FDA‑Ready Evidence 

• One‑click evidence packs suitable for submissions and audits
• Versioned archives and consistent templates
• Portfolio‑level rollups for exec and customer reporting

See results in 30‑Days | Practical and Measurable

Goal: Stand up a repeatable DevSecOps workflow that produces submission‑ready evidence mapped to FDA expectations (2025 Premarket Cybersecurity Guidance + FD&C Act §524B).

FDA measure supported: FDA‑Aligned KPIs 

• eSTAR/Technical Screening Cybersecurity Completeness ≥ 90% (no “missing cybersecurity content” holds).
  Supports Premarket Guidance Appendix 4 documentation elements & D. Submission Documentation; aligns to eSTAR technical screening expectations.
• SBOM Coverage ≥ 95% across device + variants/attachments (machine‑readable with required fields).
  Supports §524B(b)(3) SBOM + Premarket Guidance V.A.4(b).
• Median Time‑to‑Triage for exploitable HIGH CVEs ≤ 5 business days; plan established ≤ 10 business days (patch or compensating control).
  Supports §524B(b)(1) plans/procedures with documented timelines for patches/updates; Premarket Guidance VI.B.
• Justifications captured for ≥ 95% of accepted/suppressed items, with linked controls and approver sign‑off.
  Supports Security Risk Management documentation (V.A.2, V.A.6) and §524B(b)(2) reasonable assurance.
• Traceability completeness ≥ 95% (CVE → component → device version links).
  Supports Premarket Guidance Appendix 4 documentation elements; transparency across TPLC.
• Rework due to missing evidence ↓ QoQ (target: −50% by Q2).
  Supports Premarket Guidance D. Submission Documentation and Appendix 4 consistency—reducing deficiencies.

Example: When FDA Asks “Why Didn’t You Patch?”

Context: CVE‑20XX‑YYYY in openssl/libcrypto version 1.1.1u.
Device impact: The vulnerable code path is not network‑reachable in this device; TLS terminates upstream on a segregated module.
Decision: Accept with compensating controls.
Evidence captured in Helm:

• Rationale: Not externally reachable; mitigated by process isolation + strict ACLs
• Linked artifacts: Architecture diagram, test results, SBOM snapshot
• Reviewer sign‑off: Security lead + RA/QA approver with timestamps
• Trace link: CVE → component → Device XYZ v2.3.0
• Status: Accepted w/ Compensating Controls; review in next release cycle

This is the difference between “we decided” and “we can prove it.”

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What Each Stakeholder Cares About

FAQs

“We already have an SCA tool.”
Great - keep it. Helm adds device context and evidence (rationale, controls, approvals, exports) so you can submit defensibly.

“Won’t this slow engineering down?”
Policy gates and AI‑assisted explanations reduce triage time and make decisions repeatable - so you lose less time before release.

“We have dozens of variants - how do we keep up?”
Helm merges multiple SBOMs, tracks component lineage, and lets you reuse justifications across similar builds.

“What about legacy devices?”
Use Helm to build posture baselines, document mitigations, and prioritize high‑impact fixes while keeping a paper trail for customers and regulators.